Job Summary
- An Individual Contributor role
- Productive hands on programming, supporting deliverables in the study/project/portfolio/standards team, of medium – high complex statistical programming deliverables to support assets and study teams
- Performs tasks with limited supervision early in role and independently later in role.
- Is capable of handling standards/study programming specific activities independently including collaboration across stakeholders at various timezones
- Ensures adherence to high quality programming standards in their daily work
- Ensure the tasks are completed on time with quality and are compliant to the process at Pfizer with needed guidance.
- Work collaboratively with study teams and stakeholders such as clinicians and statisticians on milestones and deliverables.
- Active self-learning and delivering on solutions in the space of statistical programming and data standards
- Contribute to SDSA initiatives globally and locally.
Job Responsibilities :
- Accountable for their assigned work supporting the standards/study deliverables
- Contributes to upto 80% of their time to programming deliverables assigned within the scope of the function in either SAS, R or Python and 20% to self learning, development and growth.
- Review/Develop/Validate datasets, TFL as per CDISC aligned Pfizer Standards or Pfizer Data Standards for Study/Project/Portfolio (TA or Study Programming)
- Explore the existing code base and execute/perform runs as required, also develop/modify as per the needs and specifications suggested to the standards team as appropriate – (Standards Programming)
- Ensures appropriate documentation and QC across the lifespan of the study for all of their programming deliverables across Standards, Programming and Submissions.
- Understand/Develop/Review standard/study/project/portfolio requirements, specifications to gain deeper understanding of expectations and programming requirements, by collaborating with stakeholders.
- Knowledgeable in core safety standards as well as TA standards pertinent to their project and lead development of standards necessary for their study
- Exhibits routine and occasionally complex problem solving skills, seeking direction when appropriate.
- Regularly update leads on progress and time estimations to ensure smooth daily operations and accurate planning
- Advances job knowledge to next level by participating/contributing in/to opportunities both globally and locally.
Qualifications/ Skills:
- Bachelor or Master (preferred) Degree in Statistics, Computer Sciences, Engineering, Pharmacy, biological sciences, IT, or related field.
- 3.5 -4 years relevant experience in SAS or R programming and working knowledge of clinical trials
- Understanding of clinical data and drug development process, CDISC standards required
- Clinical trials expertise with an understanding of data operations required for the reporting of clinical trial data.
- Good understanding of ICH and regulatory guidelines
- Working knowledge of clinical data and relevant data standards
- Is able to work with stakeholders across timezones under tight timelines
- Strong written and oral communication skills, and time and project management skills
- Strong competencies and interests for innovation and problem solving
- Proven ability to operate with limited oversight
- Knowledge of at least 1 Therapeutic Area
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical
